Johnson & Johnson Careers

Senior Specialist, Clinical Data Management

Shanghai, China
Clinical Data Management


Job Description

Requisition ID: 1805685490W

• Provides task-based support to internal data managers in jobs of data management CRO oversight and takes data management accountability for assisting data management colleagues in moderate to high complexity trials and/or takes on leading data management accountability on one or more low complexity trials. Facilitates realtime inspection readiness of all China DM deliverables for clinical trial and works on archiving documents for trials.
• Makes recommendations to trial processes in line with business needs and in support of Clinical Development and Medical Affaires clinical studies. 
• Consults with internal clients on DM issues in trial conduct and database lock activities.

Qualifications
• Education /Training background:
Bachelor/Master or above degree in a scientific discipline or health related field.
• Knowledge/Skills:
Full understanding of relevant regulatory guidelines, GCP and international guidelines regarding data
management.
Understanding of the clinical drug development process in the pharmaceutical industry
Experience with DM systems e.g. Medidata Rave, ClinTrial, InForm
Understanding of current industry standards (CDISC, SDTM, CDASH...) and of technology
platforms for data exchange.
• Job experience:
Requires >=3 years of experience previously in data management and in clinical drug development
in the pharmaceutical industry.
• Competency:
Diligent and serious, precise thinking, strong sense of responsibility and accountability. Results and
performance driven, sense of urgency. Team spirit, attention to details and good self-motivated.
• Others:
Good written and verbal communication skills in Chinese and English.

Primary Location
China-Shanghai-Shanghai
Organization
J&J (China) Investments Ltd (7046)
Job Function
Clinical Data Management
Requisition ID
1805685490W